Takeda has announced plans to transfer the marketing authorisation for Moderna’s Covid-19 vaccine, Spikevax (mRNA-1273), in Japan to Moderna from 1 August this year.
On Moderna becoming the marketing authorisation holder in Japan, the company will oversee all activities linked to the vaccine including importing, local regulatory, development, quality assurance, and marketing.
The latest development concludes the memorandum of understanding under which Takeda agreed to offer distribution support for Moderna’s Covid-19 vaccines for a transitional period.
Takeda will progress to offer support to supply the vaccine under the existing national inoculation drive for the vaccines.
Moderna and Takeda will also be in charge of guaranteeing the proper implementation of operations linked to the transfer.
Moderna CEO Stéphane Bancel said: “We thank Takeda for their support and partnership in bringing our Covid-19 vaccine to Japan over the last two years, and for helping to play a key role in addressing the pandemic across the country.
“We are happy to take this important step as we continue to build and strengthen our own commercial organisation in Japan, and we look forward to continuing our partnership with Takeda in 2022.”
Spikevax obtained authorisation for special approval by the Ministry of Health, Labour and Welfare of Japan (MHLW) for a two dose-regimen to prevent Covid-19 in individuals aged 12 years or above.
A booster dose of the vaccine can be administered a minimum of five months after the second dose in individuals aged 18 years and above.
In addition, a fourth dose is indicated to be administered a minimum of five months after receiving the third dose in elderly people, taking into account the risks and benefits.
Takeda Global Vaccine Business Unit president Gary Dubin said: “Following transfer of the marketing authorisation to Moderna, we will continue to provide transitional distribution support to ensure supply continuity.”
In July last year, Takeda signed a new agreement with Moderna and the Government of Japan’s MHLW for importing and distributing 50 million doses of Moderna’s Covid-19 vaccine in the country.